Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon (HEROES-DCB)

Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Lutonix; Device: IN.PACT

Detailed Description

Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as peak systolic velocity ratio <=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Advocate Illinois Masonic Medical Center
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
    • Hazel Crest, Illinois, United States, 60429
      • Advocate South Suburban Hospital
    • Naperville, Illinois, United States, 60540
      • Edward Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62701
      • Prairie Education and Research Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease.
2. Male or non-pregnant female
3. Age greater >=18 years of age
4. Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms
5. >=1 tibial run-off vessel at baseline

6. Angiographic criteria

   • >=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate)
   • 4-7 mm vessel diameter
   • <=15 cm for planned treatment segment length.
   • Planned treatment segments are to no further proximal than 1 cm from the bifurcation of the common femoral artery and no further distal than the 1 cm above the tibioperoneal trunk.
   • Lesions treated within the target vessel are either De Novo lesions or not previously stented restenotic segments of the superficial femoral artery and/or popliteal artery that are greater than 90 days from prior angioplasty procedure
   • If the target vessel was previously stented the treated lesion must be at least 3 cm from the previously placed stent
   • Lesion must be able to be treated with either drug coated balloon device based on the sizes specifications of both devices
   • Successful, uncomplicated crossing must be possible within the treated lesion either with or without a crossing device
   • Inflow artery must be free from significant occlusive disease (< 50%) as confirmed by visual estimation by angiography otherwise the inflow artery must be treated beforehand.
   • At least 1 patent vessel outflow from the target vessel treated must be present by angiography

Exclusion Criteria:

1. Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)
2. Contra-indicated to either drug coated balloon
3. < 18 years of age at time of consent and/or index procedure
4. Pregnant or breastfeeding
5. In-stent restenosis within the target lesion
6. Previously stented target lesion/vessel.
7. Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.
8. Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment.
9. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention <=30 days of consent or randomization.
10. Presence of aneurysm in the target vessel.
11. Major amputation in the target limb.
12. Subjects who have undergone prior surgery of the superficial femoral artery/proximal popliteal artery in the target limb to treat atherosclerotic disease.
13. Use of atherectomy, laser or other debulking devices in the target limb superficial femoral artery/proximal popliteal artery during the index procedure.
14. Acute ischemia and/or acute thrombosis of the superficial femoral artery/proximal popliteal artery prior to consent or randomization.
15. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated.
16. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies.
17. On dialysis or on an immunosuppressant therapy.
18. Concomitant renal failure (including serum creatinine >2.0 mg/dL.)
19. Occurrence of myocardial infarction or cerebrovascular accident <=6 months prior to consent.
20. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
21. Unstable angina pectoris at the time of consent or randomization.
22. Septicemia at the time of consent or randomization.
23. Moderate to severely calcified lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lutonix Drug Coated Balloon; Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter	Device: Lutonix; Drug Coated Balloons
Active Comparator: IN.PACT Drug Coated Balloon; IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter	Device: IN.PACT; Drug Coated Balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency (Peak Systolic Velocity Ratio<=2.4)	Peak systolic velocity ratio <=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Revascularization Rate	To examine, describe and compare/contrast within and between Drug Coated Balloon groups.; Target lesion revascularization rate; Safety event rate; Healthcare utilization costs	12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jaafer Golzar, MD, Advocate Health Care

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimated): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: drug coated balloon; peripheral arterial disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: C5000163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO